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Serving 500+ biopharmaceutical companies globally:

US Army
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Generated: June 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 064097

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NDA 064097 describes DOXORUBICIN HYDROCHLORIDE, which is a drug marketed by Mylan Labs Ltd, Alvogen Inc, Sun Pharm Inds, West-ward Pharms Int, Actavis Inc, Pharmacia And Upjohn, Pharmachemie Bv, Teva Pharms Usa, Sandoz Inc, Fresenius Kabi Usa, Amneal Pharms Co, Sagent Pharms, Dr Reddys Labs Ltd, and Sun Pharma Global, and is included in nineteen NDAs. It is available from eleven suppliers. Additional details are available on the DOXORUBICIN HYDROCHLORIDE profile page.

The generic ingredient in DOXORUBICIN HYDROCHLORIDE is doxorubicin hydrochloride. There are seventeen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the doxorubicin hydrochloride profile page.

Summary for NDA: 064097

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 064097

Ingredient-typeAnthracyclines
Mechanism of ActionTopoisomerase Inhibitors

Suppliers and Packaging for NDA: 064097

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXORUBICIN HYDROCHLORIDE
doxorubicin hydrochloride
INJECTABLE;INJECTION 064097 ANDA West-Ward Pharmaceuticals Corp 0143-9546 0143-9546-01 1 VIAL, MULTI-DOSE in 1 BOX (0143-9546-01) > 100 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/100ML
Approval Date:Sep 13, 1994TE:APRLD:No


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Serving 500+ biopharmaceutical companies globally:

Chubb
Colorcon
UBS
Daiichi Sankyo
Novartis
US Army
Deloitte
McKinsey
Boehringer Ingelheim
Farmers Insurance

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